Director Biostatistics

Director of Biostatistics – Early-Phase Oncology Watertown, MA | Full-Time The Opportunity An innovative clinical-stage biotechnology company is seeking a Director of Biostatistics to take a highly visible, hands-on role supporting its early-phase oncology portfolio. This position will lead the statistical strategy, design, and execution of Phase I/II oncology trials , spanning First-in-Human (FIH) dose escalation through Proof-of-Concept (PoC). Unlike a traditional oversight-focused Director position, this role will remain closely involved in the data and statistical work , including trial design, modeling, programming, analysis, and interpretation of emerging clinical data. Key Responsibilities Clinical Trial Design & Statistical Strategy Lead statistical design and execution for Phase I/II oncology studies. Develop sample size calculations, randomization strategies, adaptive designs, and trial simulations. Implement early-phase dose-finding methodologies, including BOIN and other model-based approaches . Provide statistical leadership from protocol development through final Clinical Study Report (CSR). Hands-On Analysis & Programming Perform and validate statistical analyses for interim data cuts, Safety Review Committees, and Dose Escalation Meetings. Author Statistical Analysis Plans (SAPs) and develop tables, listings, and figures (TLFs). Utilize R and SAS for complex oncology analyses, simulations, and data visualization. Develop dynamic visualizations and dashboards, including tools such as R/Shiny , to communicate evolving safety, efficacy, and biomarker trends. Regulatory & CRO Oversight Support statistical strategy and data packages for INDs and other regulatory submissions. Ensure trial-level data aligns with CDISC standards, including SDTM and ADaM . Provide technical oversight of CRO biostatisticians and programmers while maintaining direct involvement in key analyses and deliverables. Cross-Functional Collaboration Serve as the statistical lead within multidisciplinary clinical development teams. Partner closely with Clinical Development, Data Management, Clinical Operations, and Biomarker/Translational teams. Integrate PK/PD and translational biomarker data into exploratory analyses to identify emerging safety and efficacy signals. Translate complex statistical findings into clear insights for senior leadership and scientific stakeholders. Qualifications PhD in Biostatistics, Statistics, or a related discipline with 6+ years of biotech/pharma experience, or MS with 8+ years of relevant industry experience. At least 3 years of hands-on experience with early-phase oncology trials (Phase I/II) . Demonstrated experience supporting oncology studies from protocol design through final CSR . Strong hands-on programming capabilities in R and SAS . Experience with early-phase trial design, dose escalation, adaptive methodologies, and statistical simulations. Strong understanding of oncology endpoints and criteria including DLT, ORR, PFS, RECIST 1.1, and/or Lugano criteria . Experience working with CDISC standards, including SDTM and ADaM . Ability to operate effectively in a fast-moving clinical development environment with frequent data cuts and evolving datasets. Strong communication skills with the ability to translate sophisticated statistical concepts into clear, actionable insights. #J-18808-Ljbffr